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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03536884
Registration number
NCT03536884
Ethics application status
Date submitted
14/05/2018
Date registered
25/05/2018
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
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Scientific title
A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
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Secondary ID [1]
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2017-003784-35
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Secondary ID [2]
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PS0015
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Universal Trial Number (UTN)
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Trial acronym
BE RADIANT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis
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Moderate to Severe Chronic Plaque Psoriasis
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0
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Condition category
Condition code
Skin
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0
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Treatment: Drugs - Secukinumab
Other interventions - Placebo
Experimental: Bimekizumab dosage regimen 1 - Subjects randomized to this arm will receive bimekizumab dosage regimen 1 (BKZ 1).
At Week 16 subjects will be re-randomized and continue to receive BKZ 1 or to switch to bimekizumab regimen 2 (BKZ 2).
Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.
Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.
Eligible subjects who completed OLE, have entered Safety Follow Up (SFU) or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Experimental: Bimekizumab dosage regimen 2 - Subjects randomized to this arm will receive bimekizumab dosage regimen 2 (BKZ 2) starting at Week 16 after initial treatment on bimekizumab regimen 1 (BKZ 1) for 16 weeks.
Placebo will be administered at pre-specified time-points to maintain the blinding over the double-blind Treatment Period.
Subjects allowed to enroll in the open-label extension (OLE) Period will receive BKZ 1 or BKZ 2. Subjects will switch from BKZ 1 to BKZ 2 at Week 64 or at the next scheduled Visit.
Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Active comparator: Secukinumab - Subjects will receive secukinumab. Subjects allowed to enroll in the open-label extension (OLE) Period will be re-randomized to receive bimekizumab dosage regimen 1 (BKZ 1) or bimekizumab dosage regimen 2 (BKZ 2).
Eligible subjects who completed OLE, have entered SFU or completed SFU would start OLE2 on BKZ 1 before switching to BKZ 2 after 16 weeks or start OLE2 on BKZ 2.
Treatment: Drugs: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Treatment: Drugs: Secukinumab
Subjects will receive secukinumab at pre-specified time-points.
Other interventions: Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI100) Response at Week 16
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Assessment method [1]
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The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
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Timepoint [1]
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Week 16
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Secondary outcome [1]
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Percentage of Participants With a PASI75 Response at Week 4
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Assessment method [1]
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The PASI75 response assessments are based on at least 75% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
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Timepoint [1]
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Week 4
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Secondary outcome [2]
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Percentage of Participants With a PASI90 Response at Week 16
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Assessment method [2]
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The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for redness, thickness, and scaling for each of the 4 body areas with score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Percentage of Participants With a PASI100 Response at Week 48
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Assessment method [3]
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The PASI100 response assessments are based on 100% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
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Timepoint [3]
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Week 48
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Secondary outcome [4]
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Percentage of Participants With a Investigator´s Global Assessment (IGA) Response (0/1) at Week 16
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Assessment method [4]
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The IGA measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response was defined as Clear (0) or Almost Clear (1) with at least a two-category improvement from Baseline at Week 16.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Number of Treatment-emergent Adverse Events (TEAEs) Adjusted by Duration of Participant Exposure to Investigational Medicinal Product (IMP) From Baseline up to Week 48
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Assessment method [5]
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The number of TEAEs adjusted by duration of exposure to study treatment was scaled such that provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
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Timepoint [5]
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From Baseline up to Week 48
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Secondary outcome [6]
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Number of Serious Adverse Events (SAEs) Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48
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Assessment method [6]
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The number of SAEs adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
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Timepoint [6]
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From Baseline up to Week 48
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Secondary outcome [7]
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Number of TEAEs Leading to Withdrawal Adjusted by Duration of Participant Exposure to IMP From Baseline up to Week 48
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Assessment method [7]
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The number of TEAEs leading to discontinuation adjusted by duration of exposure to study treatment was scaled such that it provided an incidence rate per 100 patient-years. If a participant had multiple events, the time of exposure was calculated to the first occurrence of the AE being considered. If a participant had no events, the total time at risk was used.
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Timepoint [7]
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From Baseline up to Week 48
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Eligibility
Key inclusion criteria
Double-blind Treatment Period
* Male or female at least 18 years of age
* Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
* Subject must have Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5 point scale
* Subject must be a candidate for systemic PSO therapy and/or phototherapy
* Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
* Female subject of childbearing potential must be willing to use highly effective method of contraception
Open-label extension (OLE) Period
* Completed the double-blind Treatment Period without meeting any withdrawal criteria
* All Week 48 visit assessments completed
* Compliant with ongoing clinical study requirements
* Signed a separate OLE Period Informed Consent Form (ICF)
* Female subject of childbearing potential must be willing to use highly effective method of contraception
OLE2 Period (USA and Canada)
* Completed the OLE Period without meeting any withdrawal criteria
* Compliant with ongoing clinical study requirements
* Female subject of childbearing potential must be willing to use highly effective method of contraception
* Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
* Signed a separate OLE2 Period ICF
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Double-blind Treatment Period
* Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections
* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
* Presence of active suicidal ideation or severe depression
* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
OLE2 Period (USA and Canada)
* Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
* Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
* Presence of active suicidal ideation or severe depression
* Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/08/2023
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Sample size
Target
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Accrual to date
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Final
743
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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PS0015 3 - Carlton
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Recruitment hospital [2]
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PS0015 7 - Hectorville
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Recruitment hospital [3]
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PS0015 6 - Kogarah
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Recruitment hospital [4]
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Ps0015 11 - Parkville
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Recruitment hospital [5]
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PS0015 9 - Woolloongabba
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Recruitment postcode(s) [1]
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- Carlton
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Recruitment postcode(s) [2]
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- Hectorville
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Recruitment postcode(s) [3]
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- Kogarah
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Recruitment postcode(s) [4]
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- Parkville
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Recruitment postcode(s) [5]
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- Woolloongabba
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Recruitment outside Australia
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United States of America
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California
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Connecticut
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Brussels
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Waterloo
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Toulouse
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Mahlow
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Mainz
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Bialystok
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Ostrowiec Swietokrzyski
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Wroclaw
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Alicante
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Barcelona
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Madrid
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Spain
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Sant Joan Despí
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Turkey
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Gaziantep
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Istanbul
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Kayseri
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Salford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
UCB Biopharma SRL
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).
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Trial website
https://clinicaltrials.gov/study/NCT03536884
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Trial related presentations / publications
Strober B, Paul C, Blauvelt A, Thaci D, Puig L, Lebwohl M, White K, Vanvoorden V, Deherder D, Gomez NN, Eyerich K. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. J Am Acad Dermatol. 2023 Sep;89(3):486-495. doi: 10.1016/j.jaad.2023.04.063. Epub 2023 May 12. Gottlieb AB, Warren RB, Augustin M, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM): A Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Reported Data from the BE RADIANT Phase 3b Trial. Adv Ther. 2021 Oct;38(10):5253-5269. doi: 10.1007/s12325-021-01836-1. Epub 2021 Sep 2. Yeremenko N. Out of the shadow of interleukin-17A: the role of interleukin-17F and other interleukin-17 family cytokines in spondyloarthritis. Curr Opin Rheumatol. 2021 Jul 1;33(4):333-340. doi: 10.1097/BOR.0000000000000805. Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. doi: 10.1056/NEJMoa2102383. Epub 2021 Apr 23.
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Public notes
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Contacts
Principal investigator
Name
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UCB Cares
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Address
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001 844 599 2273
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
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Available to whom?
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.Vivli.org
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/84/NCT03536884/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/84/NCT03536884/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Strober B, Paul C, Blauvelt A, Thaci D, Puig L, Le...
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Results are available at
https://clinicaltrials.gov/study/NCT03536884